NEW YORK (AP) — The death of a Massachusetts woman who took diet drugs to fit into her wedding dress has increased scrutiny of an unapproved but widely used drug cocktail known as “fen-phen.”
Before Mary Linnen of Quincy, Mass., died in February from a heart and lung disorder, drug maker Wyeth-Ayerst Laboratories Inc. warned doctors that taking its appetite suppressant, fenfluramine, with the competing phentermine is “not recommended.”
The Food and Drug Administration has never approved the combination, but doctors remain free to prescribe the two drugs together, and did so 7 million times last year.
The combination, banned in Sweden and Tennessee, is popular at weight loss centers such as Nutri/System, whose doctors wrote several thousand fen-phen prescriptions last year, company spokesman Joseph DiBartolomeo said.
Debate about the combination was rekindled when Linnen’s family filed a lawsuit on Monday against the drug makers, a Walgreen’s pharmacy and the doctor who wrote the prescription.
“Instead of walking down the aisle before a bride, I walked behind a casket,” said Mary Jo Linnen, mother of the 30-year-old woman, who was 5-feet-6 and weighed 185 to 195 pounds.
Studies show the drugs taken separately cause primary pulmonary hypertension, an elevated blood pressure of the lungs that can cause the heart to fail — the official cause of Mary Linnen’s death.
But because the drugs were not meant to be taken together, there is no authoritative research to gauge the risk of taking fen-phen.
“There’s no question that fen-phen produces primary pulmonary hypertension,” said Dr. Lewis Rubin, director of pulmonary and critical care at the University of Maryland Medical System in Baltimore. “There is no question that either drug alone can produce pulmonary hypertension. What we don’t know at this point in time is the magnitude of the risk of taking the drugs together.”
Rubin, who advised Linnen’s family about her health in late 1996, co-wrote a New England Journal of Medicine study about the link between PPH and appetite suppression. The study, conducted in Europe, found a 23-fold increase in the risk of PPH among those who took appetite suppressants, including fenfluramine. The study did not examine the fen-phen combination.
Wyeth-Ayerst spokeswoman Audrey Ashby said the company had not seen the lawsuit and would not comment on it. Because the fen-phen combination is not approved, the company does not recommend it, she said.
Despite increased scrutiny, fen-phen has a substantial cadre of supporters.
“We’ve seen very few if any side effects,” Nutri/System’s DiBartolomeo said. “I think the history shows the drugs are very safe considering they’ve been on the market for over 24 years now.”